UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
January 3, 2022
INDAPTUS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-40652 | 86-3158720 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol |
Name of each exchange on which registered |
||
Common Stock, $0.01 par value | INDP | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On January 3, 2022, Indaptus Therapeutics, Inc. (the “Company”), announced that Boyan Litchev, M.D., has been appointed to serve as the Company’s Chief Medical Officer, effective as of January 31, 2022 (the “Effective Date”).
Dr. Litchev brings more than two decades of global experience in the pharmaceutical and biotechnology industry, mainly in the clinical development of in vivo gene therapy, CAR-T and NK cells, oligonucleotides (mRNA), peptides, small molecules, and therapies for various diseases and indications. Before joining the Company, Dr. Litchev held positions of increasing responsibility at several companies, including during 2021 at Shoreline Biosciences, Inc., where he served as a Senior Vice President, Head of Clinical Development Oncology, leading all clinical and pipeline activities related to iPSC derived NK and Macrophages cell therapy. Before that, between 2020 and 2021, he served as Head of Clinical Development Oncology, Medical Affairs and Safety at Poseida Therapeutics, Inc., where he led the company’s CAR-T programs in solid tumors. Before that, between 2019 and 2020, Dr. Litchev served as an Executive Medical Director, Head of Clinical Development Oncology at Halozyme Therapeutics, Inc., leading the clinical development of four oncology programs in various stages of development. In addition, between 2017 and 2019, Dr. Litchev served as Executive Medical Director at Akcea Therapeutics, Inc., where he led all clinical and safety activities for various programs for rare and broad cardiometabolic indications and diverse pipeline with Antisense Oligonucleotides. Prior to that, Dr. Litchev held executive positions at Baxalta/Baxter/Shire (now Takeda Pharmaceutical Company Limited), and Ferring Pharmaceuticals. Earlier, Dr. Litchev was a Clinical Team Leader, Oncology at Quintiles International (now IQVIA Inc.). Prior to that he practiced as a physician and clinical researcher. Dr. Litchev earned a Medical Doctor degree from the University of Plovdiv.
In connection with his appointment as Chief Medical Officer, Dr. Litchev and the Company entered into an employment agreement (the “Employment Agreement”). The Employment Agreement provides for an annual base salary of $425,000, subject to review for an upward adjustment on at least an annual basis. Dr. Litchev is eligible to participate in an annual executive bonus plan, pursuant to which he may earn an annual target bonus of up to 40% of his base salary, based on the achievement of certain individual and company-wide objectives, which shall be established by the Company’s board of directors (the “Board”) on an annual basis. In connection with his appointment, subject to the approval of the Board, Dr. Litchev will also be entitled to an option to purchase 90,000 shares of the Company’s common stock, with one third of such shares vesting on the first anniversary of the Effective Date and the remaining shares vesting in equal monthly installments over the next two years. The Company also awarded Dr. Litchev a one-time signing bonus of $75,000, provided that, in the event Dr. Litchev terminates the Employment Agreement without good reason or for cause at any time prior to the one-year anniversary of his start date, Dr. Litchev must repay the signing bonus.
Dr. Litchev’s employment under the Employment Agreement is on an at-will basis and both the Company and Dr. Litchev has the right to terminate the agreement and his employment at any time, subject to certain notice requirements described therein. The Employment Agreement may terminate upon the earliest to occur of (i) termination by the Company without cause, subject to 30 days’ written notice, (ii) immediate termination by the Company for cause (in some cases subject to a reasonable cure period, if susceptible to cure), (iii) termination by Dr. Litchev for good reason (subject to Dr. Litchev providing written notice within 90 days after he becomes aware of the event or circumstance which he believes constitutes good reason, the Company’s failure to cure within 30 days after such notice, and Dr. Litchev’s resignation within 30 days of the expiration of such cure period), (iv) termination by Dr. Litchev without good reason, subject to 30 days’ written notice, (v) Dr. Litchev’s death, or (vi) termination by reason of Dr. Litchev’s disability.
In the event that Dr. Litchev’s employment terminates by reason of his death or disability, and Dr. Litchev is entitled to receive a bonus for the year of termination based on the achievement of pre-determined performance goals (and ignoring any continuation of employment requirements), Dr. Litchev (or his representatives) shall be entitled to receive such bonus on the same basis as the other participants in the bonus plan, except that the bonus amount shall be prorated based on the percentage of days Dr. Litchev was employed relative to the total number of days in the bonus earning period.
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Upon termination of Dr. Litchev’s employment by the Company without cause or Dr. Litchev’s resignation for good reason, Dr. Litchev will be entitled to a severance benefit equal to (i) twelve months of his base salary as in effect prior to the termination date, payable in bi-monthly installments and (ii) an amount equal to Dr. Litchev’s cost of continued health insurance coverage for six months. In addition, if Dr. Litchev is entitled to receive a bonus for the year of termination based on the achievement of pre-determined performance goals (and ignoring any continuation of employment requirements), Dr. Litchev (or his representatives) shall be entitled to receive such bonus on the same basis as the other participants in the bonus plan, except that the bonus amount shall be prorated based on the percentage of days Dr. Litchev was employed relative to the total number of days in the bonus earning period.
If Dr. Litchev’s employment is terminated by the Company without cause or by Dr. Litchev for good reason during the one year period immediately following a change in control or six months before a change in control, then Dr. Litchev will be entitled to receive, (i) twelve months of his base salary as in effect prior to the termination date plus his annual target bonus, payable in bi-monthly installments, (ii) an amount equal to Dr. Litchev’s cost of continued health insurance coverage for twelve months, (iii) the current year bonus at the target level at a prorated basis, which shall be paid within 30 days of termination, and (iv) full accelerated vesting of all of outstanding equity incentive awards upon the later of the change in control or Dr. Litchev’s termination of employment.
The Employment Agreement also includes provisions regarding confidentiality, the assignment of intellectual property to the Company, participation in the Company’s medical and similar insurance plans and reimbursement of expenses.
The foregoing summary of the Employment Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and is incorporated herein by reference.
There are no arrangements or understandings between Dr. Litchev and any other person pursuant to which he was selected as an officer, and there are no family relationships between Dr. Litchev and any of the Company’s directors or executive officers. Dr. Litchev has no direct or indirect material interest in any existing or currently proposed transaction that would require disclosure under Item 404(a) of Regulation S-K.
Item 7.01 | Regulation FD Disclosures |
On January 3, 2022, the Company issued a press release announcing the appointment of Dr. Litchev as the Company’s Chief Medical Officer. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
99.1 | Press Release dated January 3, 2022 | |
104 | Cover Page Interactive Data File (formatted as inline XBRL) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: January 3, 2022
INDAPTUS THERAPEUTICS, INC. | ||
By: | /s/ Nir Sassi | |
Nir Sassi | ||
Chief Financial Officer |
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Exhibit 99.1
Indaptus Therapeutics Announces Appointment of Boyan Litchev, M.D. as Chief Medical Officer
Seasoned Drug Developer Brings More Than Twenty Years of Medical Leadership and Clinical Oncology Experience
On Track to Initiate Phase 1 Study of Decoy20 in 2022
NEW YORK (January 3, 2022) - Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), today announces the appointment of Dr. Boyan Litchev, M.D., as Chief Medical Officer, effective January 31, 2022. Dr. Litchev will oversee clinical strategy, clinical development and the conduct of all clinical programs and will report directly to Jeffrey A. Meckler, Chief Executive Officer of Indaptus.
“We are delighted to welcome Boyan to the Indaptus team,” said Mr. Meckler. “During 2021, we transitioned Indaptus into a cutting-edge company based on a new medical modality and this appointment underscores the progress we’ve made and the potential for our novel technology. We look forward to 2022 under Dr. Litchev’s stewardship as we plan to initiate clinical studies of Decoy20. His diverse experience, including both as an oncology clinical researcher and executive leader, will provide important insights as we advance our pipeline from the bench to the bedside over the coming years.”
“This is an exciting time to join Indaptus, as the Company embarks on initiating first-in-human clinical trials with its promising proprietary platform that is designed to activate both the innate and adaptive cellular immune pathways to treat various human diseases,” said Dr. Litchev. “I look forward to working with the team and bringing my skillsets and experience as we advance this novel approach towards developing new medicines for patients with some of the highest unmet medical needs.”
Dr. Litchev brings significant experience across a multitude of medical leadership roles that are specifically relevant for Indaptus. Before joining Indaptus, Dr. Litchev served as Senior Vice President and Head of Global Clinical Development Oncology at Shoreline Biosciences. Before that, he was Head of Clinical Development Oncology, Medical Affairs and Safety at Poseida Therapeutics, where he led all activities related to CAR-T programs in solid tumors. In addition, he has held similar executive medical positions at Halozyme, Akcea Therapeutics (now Ionis Pharmaceuticals), Baxalta/Baxter/Shire (now Takeda), and Ferring Pharmaceuticals. Earlier, Dr. Litchev was a Clinical Team Leader, Oncology at Quintiles International (now IQVIA). Prior to that he practiced as a physician and clinical researcher. Dr. Litchev holds an M.D. degree from Medical University Plovdiv.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system activating signals that can be administered safely intravenously. Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, with reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. This approach has led to broad anti-tumor and anti-viral activity, including safe, durable anti-tumor response synergy with each of five different classes of existing agents, including checkpoint therapy, targeted antibody therapy and low-dose chemotherapy in preclinical models. Tumor eradication by Indaptus technology has demonstrated activation of both innate and adaptive immunological memory and, importantly, does not require provision of or targeting a tumor antigen in pre-clinical models. Indaptus has carried out successful GMP manufacturing of its lead clinical oncology candidate, Decoy20, and is currently completing other IND enabling studies.
Forward-Looking Statements
This press release contains forward-looking statements with the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies, plans and prospects. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: Indaptus’ plans to develop and potentially commercialize its technology, the timing and cost of Indaptus’ planned investigational new drug application and any clinical trials, the completion and receiving favorable results in any clinical trials, Indaptus’ ability to obtain and maintain regulatory approval of any product candidate, Indaptus’ ability to protect and maintain its intellectual property and licensing arrangements, Indaptus’ ability to develop, manufacture and commercialize its product candidates, the risk of product liability claims, the availability of reimbursement, the influence of extensive and costly government regulation, and Indaptus’ estimates regarding future revenue, expenses capital requirements and the need for additional financing following the merger. These risks, as well as other risks are discussed in the proxy statement/prospectus that was included in the registration statement on Form S-4 filed with the SEC in connection with the merger. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
Investor Contact:
Will
O’Connor
Stern Investor Relations
+1 212-362-1200
will.oconnor@sternir.com